Tecovirimat

NEW YORK, NY, USA I October 22, 2024 I SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company and leader in infectious diseases, today announced that it entered into an agreement with Vanderbilt University to obtain a license to a portfolio of preclinical fully human monoclonal antibodies (mAbs) which could be used as potential treatments for a broad range of orthopoxviruses, including smallpox and mpox. Under the agreement, SIGA has exercised its option to license the exclusive rights to develop, manufacture, and commercialize these mAbs globally. “SIGA has cultivated deep expertise in orthopoxvirus, and we are thrilled to expand our pipeline with Vanderbilt’s human monoclonal antibodies, which nicely complement our best-in-class TPOXX ® franchise. We believe these antibodies hold the potential to treat a broad spectrum of orthopoxviruses, both as a therapeutic and a prophylactic measure. By leveraging our unique capabilities in clinical development and our long-standing partnerships with U.S. Government agencies, we are well-positioned to maximize the impact of these potential new therapies,” said Diem Nguyen, SIGA Chief Executive Officer. “This license marks a step forward in our strategy to leverage our existing capabilities to create new opportunities for growth over the long term.” Developed by James Crowe, Jr., M.D., Professor of Pediatrics, Pathology, Microbiology and Immunology at Vanderbilt University Medical Center, these mABs have demonstrated promise in preclinical models and could potentially be used as standalone treatments or in combination with TPOXX ® . The U.S. Department of Defense is currently funding the development of these mAbs as potential orthopoxvirus treatments through Phase 1 clinical trials under a contract awarded to a contract manufacturing organization with biologics expertise. “Given the need for additional orthopoxvirus treatments in these unsettling times of recurring poxvirus outbreaks, my team and I are excited to work with SIGA in its future efforts to advance the development of these innovative antibodies,” said Dr. Crowe. The financial terms of the transaction were not disclosed. About SIGA SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world’s most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX ® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe and the UK for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit www.siga.com . SOURCE: SIGA

SIGA Technologies said former chief medical officer Jay Varma’s comments about the company’s experimental mpox drug are “inaccurate and misleading.” The infectious disease drugmaker had already fired Varma on Sept. 19 after secret recordings emerged of the former New York City public health advisor talking about violating Covid-19 restrictions, which he helped create during the pandemic. Varma admitted last week to taking part in parties while advising New York’s mayor during the peak of the pandemic. Mug Club , a conservative media outlet run by right-wing commentator Steven Crowder, published the videos. On Wednesday, Mug Club published another video in which Varma discusses the mpox outbreak and SIGA’s antiviral Tpoxx, or tecovirimat, which is approved in the US for smallpox but is being investigated as a potential treatment for mpox. He called into question the need for additional studies of the antiviral for mpox and said SIGA CEO Diem Nguyen would have to “decide if it’s worth it.” “It definitely looks like it works, but the people that we need to buy it are not going to be as confident in it because the data doesn’t look as strong as it would have if it were designed in a different way,” Varma said in the video. This summer, the World Health Organization again declared mpox a public health emergency. The drugmaker has contracts with the US government to supply Tpoxx. “We need to keep up the people’s belief that the drug works,” Varma said in the video, which is dated Aug. 1. “So that’s why spinning it in the media is helpful. So we want the Food and Drug Administration, the FDA, to approve our drug specifically for monkeypox.” The company said last month that the drug failed a clinical trial in children and adults in the Democratic Republic of the Congo with the endemic clade I version of the virus. The company’s stock slid more than 20% that day. At the time, SIGA said it believed the data “warrant further investigation.” Other studies are ongoing. In the video, Varma also said: “You can spin them so that people won’t, like, dump the stock, thinking that the company is worthless.” Through his spokesperson, Varma declined to talk about his commentary on SIGA, though he addressed his comments about violating Covid restrictions. Varma said the videos were “spliced, diced, and taken out of context” and that he takes “responsibility for not using the best judgment at the time” by participating in two private gatherings. In a statement, SIGA said it is “deeply angered by his comments and behavior, which do not reflect SIGA, the way we do business or our values.” After the video was published on Wednesday morning, SIGA’s share price $SIGA closed 15% lower. It was up about 2% on Thursday morning.